Diabetic Macular Edema

64
Pipeline Programs
22
Companies
50
Clinical Trials
13
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
9
3
16
5
12
19
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
788%
Small Molecule
113%
+ 47 programs with unclassified modality

On Market (13)

Approved therapies currently available

Novartis
BEOVUApproved
brolucizumab
Novartis
intravitreal2019
Novartis
CIMERLIApproved
ranibizumab-eqrn
Novartis
Vascular Endothelial Growth Factor Inhibitor [EPC]injection2022
U
DERMA-SMOOTHE/FSApproved
fluocinolone acetonide
Unknown Company
Corticosteroid [EPC]topical1988
U
DERMOTICApproved
fluocinolone acetonide
Unknown Company
Corticosteroid [EPC]otic1988
Regeneron
EYLEAApproved
aflibercept
Regeneron
Vascular Endothelial Growth Factor Inhibitor [EPC]injection2011
Regeneron
EYLEA HDApproved
aflibercept
Regeneron
Vascular Endothelial Growth Factor Inhibitor [EPC]injection2023
U
FLACApproved
fluocinolone acetonide
Unknown Company
Corticosteroid [EPC]otic2018
U
FLUOCETApproved
fluocinolone acetonide
Unknown Company
topical
U
FLUOTREXApproved
fluocinolone acetonide
Unknown Company
topical
U
ILUVIENApproved
fluocinolone acetonide
Unknown Company
Corticosteroid [EPC]intravitreal2014
Bausch + Lomb
RETISERTApproved
fluocinolone acetonide
Bausch + Lomb
Corticosteroid [EPC]intravitreal2005
Roche
VABYSMOApproved
faricimab
Roche
intravitreal2022
U
YUTIQApproved
fluocinolone acetonide
Unknown Company
Corticosteroid [EPC]intravitreal2018

Competitive Landscape

21 companies ranked by most advanced pipeline stage

Regeneron
RegeneronTARRYTOWN, NY
10 programs
3
1
4
2
AfliberceptPhase 4
Intravitreal AfliberceptPhase 41 trial
2.0 mg intravitreal afliberceptPhase 31 trial
8 mg afliberceptPhase 3
Intravitreal Aflibercept InjectionPhase 3
+5 more programs
Active Trials
NCT04588948Withdrawn0Est. Dec 2021
NCT01627249Completed660Est. Apr 2019
NCT01909791Completed702Est. Sep 2018
+1 more trials
Novartis
NovartisBASEL, Switzerland
6 programs
1
3
1
BEOVU(Brolucizumab)Phase 3Monoclonal Antibody5 trials
Labeled regime armPhase 31 trial
CIMERLI(ranibizumab)Phase 3Monoclonal Antibody5 trials
LKA651Phase 21 trial
BeovuN/A1 trial
+1 more programs
Active Trials
NCT05526729Completed222Est. Jun 2024
NCT02325271Completed40Est. Jan 2016
NCT03927690Completed91Est. Aug 2022
+11 more trials
Genentech
GenentechCA - Oceanside
6 programs
1
3
1
1
FaricimabPhase 4Monoclonal Antibody1 trial
intravitreal ranibizumab 0.3 mgPhase 21 trial
0.3 mg ranibizumabPhase 1/2Monoclonal Antibody1 trial
RanibizumabPhase 1/2Monoclonal Antibody1 trial
ranibizumab 0.3mgPhase 1/21 trial
+1 more programs
Active Trials
NCT07425522Not Yet Recruiting93Est. Nov 2028
NCT01552408Completed29Est. May 2017
NCT01292798Completed43Est. Apr 2013
+3 more trials
S
SantenCA - Emeryville
5 programs
2
1
1
1
Aflibercept Injection [Eylea]Phase 41 trial
Betamethasone MicrospherePhase 2/31 trial
SirolimusPhase 21 trial
MS-R001Phase 11 trial
NOVA63035 "Corticosteroid"Phase 11 trial
Active Trials
NCT00401115Completed50Est. Jun 2008
NCT00665106Completed20Est. Sep 2011
NCT00656643Completed131Est. May 2012
+2 more trials
Roche
RocheSTAVANGER NORWAY, Norway
4 programs
1
2
1
1
PDS Implant Pre-Filled with 100 mg/mL RanibizumabPhase 3Monoclonal Antibody1 trial
FaricimabPhase 2Monoclonal Antibody1 trial
VamikibartPhase 21 trial
RO7200220Phase 11 trial
Active Trials
NCT06771271Completed85Est. Nov 2023
NCT02699450Completed229Est. Dec 2017
NCT05151744Completed187Est. Oct 2024
+1 more trials
ANI Pharmaceuticals
4 programs
3
1
Iluvien 0.19 MG Drug ImplantPhase 41 trial
Fluocinolone AcetonidePhase 31 trial
Fluocinolone AcetonidePhase 31 trial
fluocinolone acetonidePhase 31 trial
Active Trials
NCT01304706Completed
NCT00490815CompletedEst. Apr 2011
NCT00344968CompletedEst. Dec 2010
+1 more trials
Bausch + Lomb
Bausch + LombNJ - Bridgewater
3 programs
1
1
1
1
fluocinolone acetonidePhase 2/31 trial
0.59 mg fluocinolone acetonide intravitreal implantPhase 21 trial
Bromfenac ophthalmic solutionPhase 11 trial
Active Trials
NCT00491166Unknown10
NCT00576459Completed40Est. Jul 2006
NCT00502541Completed196Est. Sep 2006
Bayer
BayerLEVERKUSEN, Germany
1 program
1
Aflibercept InjectionPhase 41 trial
Active Trials
NCT03780361Completed23Est. Feb 2024
O
OculisZUG, Switzerland
3 programs
1
1
1
Dexamethasone ophthalmic suspensionPhase 31 trial
Dexamethasone ophthalmic suspensionPhase 2/31 trial
Dexamethasone nanoparticles eye dropsPhase 21 trial
Active Trials
NCT05343156CompletedEst. Mar 2019
NCT05066997Active Not RecruitingEst. Apr 2026
NCT06172257Active Not RecruitingEst. Apr 2026
Lumenis
LumenisAustralia - Chatswood
1 program
1
Nd: YLF laser treatmentPhase 2/31 trial
Active Trials
NCT01355692Completed32Est. Jul 2015
KalVista Pharmaceuticals
2 programs
1
1
KVD001 InjectionPhase 21 trial
KVD001 InjectionPhase 11 trial
Active Trials
NCT02193113CompletedEst. Jun 2015
NCT03466099CompletedEst. Oct 2019
4D Molecular Therapeutics
1 program
1
4D-150 IVTPhase 21 trial
Active Trials
NCT05930561Active Not Recruiting72Est. Feb 2029
Aviceda Therapeutics
Aviceda TherapeuticsMA - Cambridge
1 program
1
AVD-104Phase 21 trial
Active Trials
NCT06181227TerminatedEst. Apr 2024
Rezolute
RezoluteREDWOOD CITY, CA
1 program
1
Experimental: Group 1 - 50mg RZ402Phase 21 trial
Active Trials
NCT05712720CompletedEst. Apr 2024
SciNeuro Pharmaceuticals
SciNeuro PharmaceuticalsChina - Shanghai
1 program
1
SNP318Phase 21 trial
Active Trials
NCT07199777Not Yet Recruiting60Est. Mar 2027
Opko Health
Opko HealthMIAMI, FL
1 program
1
bevasiranibPhase 2Small Molecule1 trial
Active Trials
NCT00306904CompletedEst. Dec 2007
Alcon
AlconFORT WORTH, TX
1 program
1
LKA651 ophthalmic solutionPhase 1
Molecular Partners
Molecular PartnersSchlieren-Zurich, Switzerland
1 program
1
MP0112Phase 11 trial
Active Trials
NCT01042678Terminated18Est. Dec 2010
Therini Bio
Therini BioCA - Sacramento
1 program
1
THN391 MADPhase 11 trial
Active Trials
NCT06701721RecruitingEst. Feb 2026
Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
1 program
Describing Patient With DME, Their Patient Journey and Disease ProgressionN/A1 trial
Active Trials
NCT05966753Completed221,004Est. Dec 2023
NV
Notal VisionVA - Manassas
1 program
Notal Vision Home OCTN/A1 trial
Active Trials
NCT05745116UnknownEst. Jul 2023

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
NovartisBrolucizumab
NovartisBrolucizumab
NovartisBrolucizumab
GenentechFaricimab
NovartisBrolucizumab
NovartisBrolucizumab
Novartisranibizumab
ANI PharmaceuticalsIluvien 0.19 MG Drug Implant
NovartisBrolucizumab
BayerAflibercept Injection
SantenAflibercept Injection [Eylea]
RegeneronIntravitreal Aflibercept
Novartisranibizumab
Novartisranibizumab
Novartisranibizumab

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 5,089 patients across 50 trials

Post Marketing Study to Evaluate the Safety and Effectiveness of Brolucizumab in Patients With Diabetic Macular Edema.

Start: Dec 2024Est. completion: Feb 202663 patients
Phase 4Active Not Recruiting

Brolucizumab Efficacy and Safety Single-Arm Descriptive Trial in Patients With Persistent Diabetic Macular Edema

Start: Jul 2024Est. completion: Jul 202552 patients
Phase 4Active Not Recruiting

Study to Evaluate the Safety and Effectiveness of Intravitreal Injections (IVI) of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD)

Start: Mar 2022Est. completion: Aug 2023105 patients
Phase 4Completed

A Study to Investigate Faricimab Treatment Response in Treatment-Naive, Underrepresented Patients With Diabetic Macular Edema

Start: Feb 2022Est. completion: Jan 2027218 patients
Phase 4Active Not Recruiting

Study of Innovative Multimodal Imaging Biomarkers to Predict Anatomical Outcome in Naive Patients With wAMD Treated With Brolucizumab.

Start: Oct 2021Est. completion: Oct 2023122 patients
Phase 4Completed

Efficacy and Safety of Two Different Brolucizumab 6 mg Dosing Regimens in Neovascular Age-related Macular Degeneration

Start: Jul 2021Est. completion: Jan 202452 patients
Phase 4Completed

Pre-vitrectomy Intravitreal Ranibizumab for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Edema

Start: Sep 2020Est. completion: Jun 2022142 patients
Phase 4Unknown
NCT04469595ANI PharmaceuticalsIluvien 0.19 MG Drug Implant

A Study of Intravitreal ILUVIEN® Implant as Baseline Therapy in Patients With Early Diabetic Macular Edema (DME)

Start: Aug 2020Est. completion: Dec 2024
Phase 4Active Not Recruiting

Intravitreal Brolucizumab in Neovascular Age-related Macular Degeneration With Limited Response to Aflibercept

Start: Jul 2020Est. completion: Nov 202116 patients
Phase 4Terminated
NCT03780361BayerAflibercept Injection

Changes in Inflammatory Biomarkers Including Soluble CD14 and Hyperreflective Foci in DME Patients Treated With Aflibercept (FORESIGHT)

Start: May 2019Est. completion: Feb 202423 patients
Phase 4Completed
NCT03197480SantenAflibercept Injection [Eylea]

Diabetic Macular Edema Asian Response (DEAR) Study: Biomarkers for Response to Aflibercept in Asian Patients With Center Involving DME

Start: Apr 2019Est. completion: Mar 2021
Phase 4Unknown
NCT03059277RegeneronIntravitreal Aflibercept

Intravitreal Alfibercept for Center Involved DME Previously Managed With Intravitreal Ranibizumab

Start: Jun 2018Est. completion: Sep 20200
Phase 4Withdrawn

Study to Show a Superior Benefit in Terms of Reduction of Ranibizumab Injections in Patients Receiving Ranibizumab Plus Laser Photocoagulation Combination Therapy Without Loss of Efficacy and Safety

Start: Dec 2016Est. completion: Dec 201859 patients
Phase 4Completed

Intraocular Cytokine in Recurrence of Polypoidal Choroidal Vasculopathy

Start: Nov 2016Est. completion: Jan 202028 patients
Phase 4Unknown

24 Week Study to Compare Systemic VEGF-levels of Ranibizumab and Aflibercept in DME.

Start: Sep 2016Est. completion: Sep 20170
Phase 4Withdrawn

Comparison of PDT Combination With Ranibizumab vs. Ranibizumab Monotherapy in Persistent PCV With Initial Loading Dose

Start: Sep 2016Est. completion: Jan 201940 patients
Phase 4Unknown

Functional and Structural Outcomes in Neovascular Age-related Macular Degeneration

Start: Aug 2016Est. completion: Nov 201771 patients
Phase 4Completed

Effects of Intravitreal Ranibizumab for Macular Edema With Nonproliferative Diabetic Retinopathy

Start: Aug 2016Est. completion: Dec 201925 patients
Phase 4Completed

CANadian Study in Patients With Wet AMD, Evaluating the Efficacy and Safety of Switching From Intravitreal Aflibercept to RanIbizumab

Start: Mar 2016Est. completion: Dec 20170
Phase 4Withdrawn

Head to Head Study of Anti-VEGF Treatment.

Start: Jan 2016Est. completion: Jul 201612 patients
Phase 4Completed

Systemic VEGF Protein Dynamics Following Intravitreal Injections of Ranibizumab Versus Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema

Start: Oct 2015Est. completion: Oct 20160
Phase 4Withdrawn

Efficacy and Safety of Lucentis® (Ranibizumab Intravitreal Injections) in Chilean Patients With Diabetic Macular Edema.

Start: Apr 2015Est. completion: Dec 201621 patients
Phase 4Completed

Systemic Vascular Endothelial Growth Factor (VEGF) Protein Dynamics Following Intravitreal Injections of Ranibizumab Versus Aflibercept in Patients With Neovascular Age-related Macular Degeneration

Start: Apr 2015Est. completion: Jun 201741 patients
Phase 4Completed

Study of Efficacy of Ranibizumab in Different Regimens in Patients With Diabetic Macula Edema

Start: Feb 2015Est. completion: Jun 2017135 patients
Phase 4Completed

Safety and Efficacy of Switching From Aflibercept to Ranibizumab in Patients With nAMD

Start: Aug 2014Est. completion: Sep 2017103 patients
Phase 4Completed

Combination of Standard Lucentis Therapy With Micropulse Diode Laser for the Treatment of Diabetic Macular Edema

Start: Apr 2014Est. completion: Dec 201725 patients
Phase 4Unknown

UNcovering the Difference Between Ranibizumab and Aflibercept, Focusing on Systemic Anti-vascular Endothelial Growth Factor (VEGF) Effects in Patients With neovascuLar Age-related Macular Degeneration (AMD)

Start: Apr 2014Est. completion: Sep 2015205 patients
Phase 4Completed

Safety and Tolerability of Ranibizumab in Mono/Bilateral Wet Age Related Macular Degeneration (w-AMD) Patients in Eyes With BCVA<2/10 and/or 2nd Affected Eye

Start: Mar 2014Est. completion: Jun 20161,049 patients
Phase 4Completed

Retinal Ganglion Cell Function After Intravitreous Ranibizumab in Patients With Diabetic Macular Edema

Start: Mar 2014Est. completion: Jul 20150
Phase 4Withdrawn

Evaluation of the Usefulness of a Treat and Extend Regimen Using Ranibizumab for Neovascular AMD.

Start: Jan 2014Est. completion: Mar 201978 patients
Phase 4Completed

Evaluation of the Usefulness of a PRN Regimen Using Ranibizumab for Macular Edema Due to Branch Retinal Vein Occlusion

Start: Jan 2014Est. completion: Mar 201927 patients
Phase 4Completed

Efficacy of Ranibizumab Prn Treatment Compared to Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability in Patients With Wet AMD

Start: Oct 2013Est. completion: May 2017712 patients
Phase 4Completed

Visual Outcome in Patients With Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV) Treated With Either Ranibizumab as Monotherapy or Combined With Verteporfin Photodynamic Therapy (vPDT)

Start: Aug 2013Est. completion: Mar 2017321 patients
Phase 4Completed

Ranibizumab for Macular Edema Secondary to Branch Retinal Vein Occlusion in Patients With Fair Vision

Start: Jan 2013Est. completion: Dec 201719 patients
Phase 4Terminated

Extension Study to Compare Long-term Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With RVO

Start: May 2012Est. completion: Oct 2014175 patients
Phase 4Completed

Ranibizumab in Diabetic Vitrectomy. A Prospective, Randomised Controlled Trial of Ranibizumab Pre-treatment in Diabetic Vitrectomy - a Pilot Study

Start: Mar 2011Est. completion: Mar 201330 patients
Phase 4Completed

A Clinical Study in Current Medical Practice of the Efficacy and Safety of Ranibizumab 0.5mg in Diabetic Patients Presenting a Visual Impairment Due to Macular Edema

Start: Feb 2011Est. completion: Aug 2012394 patients
Phase 4Completed

Ranibizumab "Treat and Extend" in Diabetic Macular Edma

Start: Jan 2011Est. completion: Nov 20127 patients
Phase 4Completed

Ranibizumab Treatment of Diabetic Macular Oedema With Bimonthly Monitoring After a Phase of Initial Treatment

Start: Jan 2011Est. completion: Apr 2013111 patients
Phase 4Completed

Lucentis (Ranibizumab) in Diabetic Macular Oedema: a Treatment Evaluation

Start: Oct 2010Est. completion: Jul 201237 patients
Phase 4Completed

Indocyanine Angiographic Changes of Choroidal Neovascularization by Ranibizumab

Start: Oct 2010Est. completion: Feb 201349 patients
Phase 4Completed

Efficacy Study of Ranibizumab on Patients With Age-related Macular Degeneration.

Start: Apr 2010Est. completion: Mar 201340 patients
Phase 4Completed

Comparison of Safety, Effectiveness and Quality of Life Outcomes Between Labeled Versus "Treat and Extend" Regimen in Turkish Patients With Choroidal Neovascularisation Due to Age-related Macular Degeneration (AMD)

Start: Feb 2010Est. completion: Apr 201299 patients
Phase 4Completed

Intravitreal Ranibizumab in Retinal Pigment Epithelial Detachments

Start: Dec 2008Est. completion: Dec 201540 patients
Phase 4Completed

Efficacy and Safety of Verteporfin Added to Ranibizumab in the Treatment of Symptomatic Macular Polypoidal Choroidal Vasculopathy

Start: Apr 200861 patients
Phase 4Completed

Safety and Tolerability of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration

Start: Jul 2007Est. completion: Jan 2010234 patients
Phase 4Completed

Reduced Fluence Photodynamic Therapy (PDT) With Visudyne in Combination With Lucentis for Age-Related Macular Degeneration

Start: May 2007Est. completion: Apr 201031 patients
Phase 4Completed

Combination Lucentis and Ocular Photodynamic Therapy With Visudyne, With Evaluation-based Retreatment

Start: Feb 2007Est. completion: Oct 200910 patients
Phase 4Completed

Lucentis Utilizing Visudyne (LUV Trial) Combination Therapy in the Treatment of Age-Related Macular Degeneration

Start: Jan 2007Est. completion: Jan 20097 patients
Phase 4Terminated
NCT06172257OculisDexamethasone ophthalmic suspension

A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 2)

Start: Mar 2024Est. completion: Apr 2026
Phase 3Active Not Recruiting

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

12 late-stage (Phase 3) programs — potential near-term approvals
22 companies competing in this space